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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Fluoroscopic, Image-Intensified
510(k) Number K904012
Device Name PHILIPS INTEGRIS I 2000 SYSTEM
Applicant
Philips Medical Systems, Inc.
Veenpluis 4-6
P.O. Box 10000
5680 Da Best,  NL
Applicant Contact KELLY A DIAZ
Correspondent
Philips Medical Systems, Inc.
Veenpluis 4-6
P.O. Box 10000
5680 Da Best,  NL
Correspondent Contact KELLY A DIAZ
Regulation Number892.1650
Classification Product Code
JAA  
Date Received08/29/1990
Decision Date 11/29/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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